Coherus Acquires Commercial Rights for Avastin® Biosimilar in the United States
- Category: Antibodies
- Published on Monday, 13 January 2020 17:43
- Hits: 1810
Agreement Includes an Option for Rituxan® Biosimilar
REDWOOD CITY, CA, USA I January 13, 2020 I Coherus BioSciences, Inc. (“Coherus” or the “Company”, Nasdaq: CHRS), today announced the Company has entered into a licensing agreement with Innovent Biologics, (Suzhou) Co., Ltd., (“Innovent”), a leading biopharmaceutical company headquartered in China, to commercialize Innovent’s biosimilar candidate to Avastin® (bevacizumab) in the United States and Canada. Coherus plans to file a Biologics License Application (“BLA”) with the U.S. Food and Drug Administration (“FDA”) in late 2020 or early 2021 depending on FDA interaction timing, and to launch directly upon approval. The Company anticipates completing a single dose pharmacokinetic clinical study and certain analytical/bioanalytical exercises to support the U.S. filing. Innovent’s Avastin biosimilar successfully completed a large Phase 3 safety and efficacy study in China, and the application was filed for approval and was accepted by the National Medical Products Administration (“NMPA”) in China in January 2019, and subsequently granted priority review status. Also, under the terms of the agreement, Coherus acquired an option to commercialize Innovent’s biosimilar to Rituxan® (rituximab) in the United States and Canada. Innovent’s Rituxan biosimilar was filed for approval and accepted by the NMPA in China in June 2019, and subsequently granted priority review status.
The agreement furthers the Company’s previously-stated strategic objective to expand its oncology franchise and leverage its commercial infrastructure in the United States. Coherus expects to apply its biosimilar regulatory expertise to convert the Chinese regulatory filing into a FDA biologics application.
“We are excited to enter into a strategic collaboration with one of the premier Chinese biologics companies,” said Denny Lanfear, Chairman and Chief Executive of Coherus. “Innovent is an impressive fully-integrated organization delivering substantial benefits to the healthcare system and patients in China with their first approved and successfully commercialized PD-1. Its oncology therapeutics complement UDENYCA® and advance our core mission to expand choice, improve patient access and lower healthcare costs in the United States.”
“UDENYCA® has been the most successful biosimilar launch in the United States and has made Coherus the obvious partner of choice,” said Michael Yu, Ph.D., Founder, Chairman and CEO of Innovent. “Coherus and Innovent share a very similar mission, vision and set of values. We are pleased and proud to be working together.”
Oncology is one of three focus areas for the Company along with ophthalmology and immunology. In the fourth quarter of 2019, Coherus announced it had acquired rights to commercialize BioEq’s Lucentis® biosimilar in the United States, the lead asset in Coherus’ ophthalmology franchise.
According to the terms of the agreement with Innovent, Coherus will pay up to $45 million in milestones, including the upfront, for its Avastin biosimilar upon achieving certain regulatory and commercialization goals, as well as customary double-digit royalty payments. Financial terms for Innovent’s Rituxan biosimilar will be the same when optioned.
Avastin®, Rituxan® and Lucentis® are registered trademarks of Genentech, Inc.
About Coherus BioSciences, Inc.
Coherus is a leading biosimilar company that develops and commercializes its own high-quality therapeutics as well as those of others seeking capable access to the United States market. Biosimilars are intended for use in place of existing, branded biologics to treat a range of chronic and often life-threatening diseases, with the potential to reduce costs and expand patient access. Composed of a team of proven industry veterans with world-class expertise in process science, analytical characterization, protein production, sales and marketing and clinical-regulatory development, Coherus is positioned as a leader in the global biosimilar marketplace. Coherus commercializes UDENYCA® (pegfilgrastim-cbqv) in the U.S. and has received regulatory approval for UDENYCA® in the European Union. Coherus is advancing late-stage clinical products CHS-1420 (adalimumab biosimilar), Bioeq’s Lucentis (ranibizumab) biosimilar and Innovent’s Avastin (bevacizumab) biosimilar towards commercialization, and early-stage clinical products, CHS-2020, an Eylea (aflibercept biosimilar), and CHS-131, a small molecule for nonalcoholic steatohepatitis (NASH) and multiple sclerosis. For additional information, please visit www.coherus.com.
SOURCE: Coherus Biosciences